Compounded Weight Loss Medications
What is the difference between different GLP-1RA drugs?
Byetta was the first GLP-1RA approved by the FDA in 2005. It was based on Exendin-4, the GLP-1RA in the Gila monster lizard. It was a twice a day injection that often gave welts at the site of the injection. Semaglutide (brand name Ozempic, Wegovy, made by Novo Nordisk) took the structure of Exendin-4 and made it more long-lasting, so it could be given as a weekly shot. Ozempic was approved by the FDA for diabetes in 2017 and Wegovy was approved for obesity in 2021. Scientists then combined the glucose-dependent insulinotropic polypeptide (GIP) with a glucagon- like peptide-1 (GLP-1) receptor agonist to come up with Tirzepatide which is a “twincretin.” This drug, made by Lilly, was approved by the FDA for diabetes as Mounjaro in 2022 and Zepbound was approved for obesity in 2023. Tirzepatide has very impressive weight loss properties with patients on the highest dose losing up to 25 pounds. It often has less side effects than semaglutide, especially less nausea, because it contains GIP, which helps secrete insulin when blood sugar is high. It is Dr. Friedman’s go to drug for weight loss, all things being equal. Because Tirzepatide it is more effective for weight loss than semaglutide, it is often more cost-effective.
Compounding Pharmacies that Compound GLP-1RAs
With the increasing demand for GLP-1RAs, high commercial cost and limited supply, compounded pharmacies started compounding these drugs for the patients at a fraction of the cost of brand-name drugs at commercial pharmacies. They were allowed to do this because the FDA deemed that there was a shortage of brand-name drugs, since they were compounding Tirzepatide and Semaglutide and not the brand-names Ozempic, Wegovy, Mounjaro and Zepbound, and because they were able to supply in-between dose or added ingredients such as Glycine + B12. However, in October 2024, the FDA under influence from Lilly declared the shortage of Mounjaro and Zepbound “resolved” and told compounding pharmacies to stop distributing compounded versions of these drugs. However, the shortage of Mounjaro and Zepbound was not over and there is legal action between compounding pharmacies and the FDA. The FDA announced later in October 2024 that compounding pharmacies can continue making Tirzepatide while the FDA reconsiders its decision to remove the drug from its shortage list. Dr. Friedman agrees that compounding pharmacies are supplying a helpful service to patients and should continue to supply these medicines. Although he cannot predict the future, Dr. Friedman expects compounding pharmacies to continue to supply these drugs and expand their use as providers realize these are good options for patients. Dr. Friedman posits that Lilly pressured the FDA to say the shortage was over purely for profit making reasons.
Individual Dosing
Another advantage of GLP-1RAs from compounding pharmacies over brand name products is that compounding pharmacies prescribed vials and syringes, so the dose can be individualized, while Wegovy, Zepbound and Mounjaro come as single-use, fixed-dose cartridges. Ozempic is designed for multiple fixed-dose delivery, but by using “clicks” patients can give individualized dosing. In contrast, compounding Semaglutide and Tirzepatide can be given in whatever dose the patient and doctor decide on. Patients can start on a very low dose (micro-dosing) and work their way up, so side effects are minimized. Patients have the leeway to adjust their own dose depending on appetite suppression and side effects, as well as costs. This is a major advantage of the compounded drugs.
Are Compounding Pharmacies safe?
First it depends on the compounding pharmacy. Dr. Friedman has researched compounding pharmacies across the country and has found a few that he trusts to make a safe product. He does not recommend random compounding pharmacies on the internet or using companies that have virtual doctors prescribing these medicines to patients at a profit without having a doctor-patient relationship. Dr. Friedman only recommends compounding pharmacies that are Accredited by the Pharmacy Compounding Accreditation Board (PCAB). At the compounding pharmacies below, each batch is tested for sterility and potency by a 3rd party independent laboratory and provides a Certificate of Analysis.
Second, these medicines, even brand name versions, have side effects. While nausea, decreased appetite, and constipation are common for both brand name and compounded pharmacies, more serious side effects including pancreatitis and bowel obstruction can also occur with both sources. As these drugs are widely prescribed, the number of these anecdotal side effects may seem large, but as a percentage they are low. Dr. Friedman has not seen data that the side effects are more common among compounded pharmacies than brand-name pharmacies. In fact, side effects are likely less with compounded versions due to the ability to give individualized dosing.
Both compounding pharmacies and pharmaceutics batch process their drugs using sterile conditions. While Novo Nordisk and Lilly have spent millions on their production plants and certainly make sure their products are of high quality, Dr. Friedman is not convinced that compounded products are inferior.
Which Compounding pharmacies does Dr. Friedman use for GLP-1RAs?
Dr. Friedman’s go to compounding pharmacy is University Compounding Pharmacy (UCP) which is a503A pharmacy. Dr. Friedman has used this pharmacy based in San Diego for decades. Their price is reasonable, and they can ship multiple vials with each order. They ship to all states except Alabama, Arkansas, Iowa, Mississippi, North Carolina, and Washington DC. Prescribing is easy and after Dr. Friedman prescribes your medicine, they contact you for shipping and billing information (patients pay them directly). The vials plus free syringes and alcohol pads arrive refrigerated in 2-3 days. Contact Dr. Friedman’s office for other options. Compounded GLP-1RAs are only available for established patients of Dr. Friedman. He usually prescribes Tirzepatide but may also prescribe Semaglutide.
How long are the compounded vials good for?
Officially, the CDC recommends most multidose vial be discarded 28 days from first puncture. However, UCP has performed potency, stability, and sterility testing which allows them to guarantee the medication unopened for 50 days and is doing testing that confirms that. Dr. Friedman recommends that refrigerated unopened vials can be used for a year and refrigerated open vials can be kept for 90 days. Please let us know which dose you want and how many vials.
Side effects of Tirzepatide and Semaglutide
The most common side effects for both drugs include nausea and constipation. Patients also report acid reflux, fatigue, stomach pain, vomiting, burping and diarrhea. Depression and anxiety often improve, but can worsen. Muscle loss can occur, and Dr. Friedman recommends increasing protein intake (plant-based protein, if possible). The side effect of nausea is less common with Tirzepatide and can be minimized with both drugs by eating small meals and drinking a lot of fluid. Dr. Friedman can prescribe Zofran for nausea if needed. Both drugs should not be used if the patient or any family members have been diagnosed with Multiple Endocrine Neoplasia Syndrome Type 2 or Medullary thyroid cancer. Other types of thyroid cancer are okay.
Goodhormonehealth Webinars
Patients should listen Dr. Friedman’s GoodHormoneHealth Webinar on November 17, 2024 on compounded Tirzepatide vs Semaglutide for patients with endocrine problems:
https://www.facebook.com/goodhormonehealth
or listen to his Podcast on your favorite Podcast channels.
Please visit https://www.goodhormonehealth.com/weight-loss/ for more information.
We look forward to having compounded GLP-1s help you achieve good hormone health.